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Endoplasmic Reticulum Stress Relieving Agent

Taurourodeoxycholic Acid (TUDCA) for Type 1 Diabetes

Phase 2
Waitlist Available
Led By Rudolph Leibel, MD
Research Sponsored by Robin Goland, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

Clinically, the ability to slow or prevent beta cell demise can prevent or improve the course of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent major pathological basis for the disease, has led to efforts to prevent or suppress this immune assault. Here we propose to buttress the beta cell's capacity to withstand this assault by improving the function of the endoplasmic reticulum stress resolving mechanisms within these cells. The ability to do so could have a major impact on preventive and therapeutic strategies for type 1 diabetes (and possibly other types of diabetes). The type of endoplasmic reticulum stress relieving agent (TUDCA) proposed here could ultimately be applied on an anticipatory basis to individuals at high risk for type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C-peptide measurement as reflection of insulin secretion
Secondary outcome measures
Endoplasmic reticulum stress
liver function tests

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Taurourodeoxycholic Acid (TUDCA)Experimental Treatment1 Intervention
TUDCA 1750 mg/day x 12 months
Group II: Sugar pill (placebo)Placebo Group1 Intervention
Placebo at same dose, frequency, and duration as experimental treatment

Find a Location

Who is running the clinical trial?

Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,764 Total Patients Enrolled
Robin Goland, MDLead Sponsor
Rudolph Leibel, MDPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Apr 2025